The Clinical Project Manager at WEP Clinical is responsible for the setup, implementation, and management of clinical trials, ensuring patient safety, data integrity, and high-quality delivery in compliance with applicable regulations.
This role provides leadership across cross-functional teams, manages client relationships, and is accountable for delivering clinical trials on time, within scope, and within budget.
The Ideal Candidate:
- Adaptable
- Detail-oriented
- Collaborative
- Solutions-focused
What You'll Do:
- Lead the setup, execution, and close-out of clinical trials in compliance with WEP Clinical SOPs, GCP/ICH guidelines, and regulatory requirements.
- Provide day-to-day accountability for the operational delivery of assigned clinical trials.
- Develop and maintain study manuals, operational project plans, timelines, and key performance metrics.
- Ensure proper setup, maintenance, and close-out of eTMF and CTMS systems.
- Serve as project team lead and primary point of contact for internal and external stakeholders.
- Provide oversight and coordination of cross-functional deliverables including monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing.
- Ensure internal and external teams are appropriately trained on study protocols and operational requirements.
- Act as the primary client contact for clinical trial operations, deliverables, and issue resolution.
- Lead internal and external meetings, ensuring alignment on project status, risks, and timelines.
- Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle.
- Implement mitigation strategies and corrective actions where required.
- Oversee submissions to IRB/ECs and review informed consent forms as required.
- Ensure compliance with regulatory requirements and internal quality standards.
- Collaborate with Quality Assurance to support audits, CAPAs, and investigations as appropriate.
- Manage project budgets, scope, and financial performance.
- Oversee vendor performance and deliverables, including review and approval of invoices.
- Review site payments and ensure alignment with Clinical Trial Agreements.
- Maintain accurate and complete trial documentation within internal systems (e.g., SharePoint).
- Ensure all trial records meet quality and compliance standards.
What You'll Need:
- Bachelor’s Degree (health or science field preferred)
- Minimum 5 years’ experience in a Project Manager role within clinical trials or clinical research
- Demonstrated experience managing clinical trials from initiation through close-out
- Strong working knowledge of ICH GCP guidelines and clinical trial processes
- Proven ability to lead cross-functional teams and manage multiple priorities
- Strong organizational, problem-solving, and decision-making skills
- Effective verbal and written communication skills
- Proficiency in Microsoft Office tools
- Ability and willingness to travel as required for business needs
- This role may be filled at different levels depending on experience and demonstrated capability.
- Responsibilities may expand in scope with increased seniority and complexity of assigned projects.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message.
We will never ask for your bank account information at any stage of recruitment.
Skills Required
- Bachelor's degree (health or science field preferred)
- Minimum 5 years' experience in a Project Manager role within clinical trials or clinical research
- Demonstrated experience managing clinical trials from initiation through close-out
- Strong working knowledge of ICH GCP guidelines and clinical trial processes
- Experience with eTMF and CTMS systems
- Proven ability to lead cross-functional teams and manage multiple priorities
- Experience with regulatory submissions to IRB/ECs and reviewing informed consent forms
- Experience in vendor management, budgeting, and financial oversight of projects
- Strong organizational, problem-solving, decision-making, and communication skills
- Proficiency in Microsoft Office tools
- Ability and willingness to travel as required for business needs
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
